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July 05, 2016

Sen. Chuck Grassley of Iowa and Sen. Sherrod Brown of Ohio are urging the federal Centers for Medicare and Medicaid Services (CMS) to maintain current policy requiring that Medicare prescription drug plans carry six categories of prescription drugs offered to participating beneficiaries. Grassley and Brown are the sponsors of legislation requiring the maintenance of the “six protected classes.” The agency earlier tried to limit the categories by regulation, then dropped its plans after public outcry. Grassley and Brown are concerned that CMS might try again.

“Despite Part D’s success and the effectiveness of the six protected classes policy, the Medicare Payment Advisory Commission (MedPAC) report released earlier this month included a recommendation to make changes to this popular policy,” Grassley and Brown wrote to Acting CMS Administrator Andy Slavitt. “In its recommendation, however, MedPAC acknowledges that ‘the degree to which plans could achieve potential savings is unclear.’ Regardless of potential savings, we maintain serious concerns with MedPAC’s recent proposal and urge CMS to maintain the six protected classes policy as it currently exists.”

Under current policy, Medicare Part D plans must include all covered drugs in six protected categories and classes in their plan formularies: anticonvulsants, antidepressants; antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants for the treatment of transplant rejection. The policy is meant to “safeguard access to lifesaving medicines for vulnerable Medicare beneficiaries who rely on these classes of prescription drugs to protect them from potential challenges associated with any interruption of therapy,” Grassley and Brown wrote.

In January 2014, CMS issued proposed rules that would have narrowed the protected classes to anticonvulsants, antiretrovirals, and antineoplastics, beginning in plan year 2015. Antipsychotic drugs would have continued to be treated as a class of clinical concern in 2015 and until CMS determined that it was appropriate to change the criteria for these products.

In February 2014, the entire Finance Committee, which oversees Medicare, wrote to CMS with concerns about disrupting beneficiary care. After hearing from Congress and other concerned groups, in May 2014, CMS announced it would not finalize the proposed regulations relating to the six protected classes.

In March 2015, Grassley and Brown introduced the Medicare Formulary Improvement Act (S. 648) to clarify congressional intent that Part D plan sponsors are required to include all covered drugs in the six protected classes. Grassley and Brown are on the Finance Committee. Grassley is former chairman.